Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
NCT ID: NCT05053620
Last Updated: 2023-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
22 participants
OBSERVATIONAL
2021-10-19
2023-04-18
Brief Summary
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Detailed Description
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A preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Single arm
All patients.
Calculation of the arcuate intrasomal incisions
All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
Interventions
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Calculation of the arcuate intrasomal incisions
All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
Eligibility Criteria
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Inclusion Criteria
2. Low corneal astigmatism, between 0.50D and 1.25D.
Exclusion Criteria
2. Keratoconus.
3. Corneal scars
4. Pterygium
5. Glaucoma
18 Years
ALL
No
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
OFTALVIST (Oftalmología Vistahermosa S.L)
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Tañá Rivero, Doctor
Role: PRINCIPAL_INVESTIGATOR
OFTALVIST (Oftalmología Vistahermosa S.L)
Locations
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OFTALVIST (Oftalmología Vistahermosa S.L.)
Alicante, , Spain
Countries
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Other Identifiers
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ARCUATAS
Identifier Type: -
Identifier Source: org_study_id
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